The effectiveness of a pharmacovigilance system depends on the active participation of all, mainly health professionals, who are most suitable to report suspected adverse reactions observed in patients during daily practice.
Where can we report an adverse event and who are required to do so?
The Format for the Report of Suspicion of Adverse Events to Medicines (FOREAM) is the official mechanism to report any adverse reaction or event to medications in Colombia.
Many laboratories also have links on their website to report adverse events directly to their Pharmacovigilance department .
On the other hand, holders of health records (pharmaceutical industry) are required to report adverse events to INVIMA. Serious events must be reported within 72 hours of detection and non-serious events every two months.
Why is the Complete Filling of the Adverse Event Report Important?
Spontaneous notifications are currently the greatest source of information on adverse reactions, therefore it is important that all the fields established in this report are filled out, especially the information (minimum requirements of a valid report) related to:
- The reporter
- The consumer or patient (age, sex, initials)
- Adverse reaction
- Suspicious medication
All the information requested by the adverse event report is used to carry out the investigation of the cases and to establish the causal relationship between the event and the suspect drug.